MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-12 for 9FR. EHL PROBE FOR AEH-4 E4-9F manufactured by Northgate Technologies.
[53044492]
The device was not returned to olympus for evaluation. The cause for the reported event cannot be determined. The instruction manual gives several warnings in an effort to prevent probe damage. ? Upon receipt and prior to use, examine the insulation of the probe for splits, cracks, holes, or other imperfections. Do not use a damaged product and contact olympus. Each shot depletes some portion of the useful life of the probe. Because each electrohydraulic lithotripsy procedure is different, the stresses on an individual probe vary significantly.?
Patient Sequence No: 1, Text Type: N, H10
[53044493]
Olympus was informed that during a bladder stone procedure, the physician noted metal fibers exposed at the distal tip of the probe. It was reported that due to the hardness of the stone, three additional probes were used to complete the procedure. The physician reported that the use of the additional probes is not unusual due to the hard stone. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[58859054]
The device was returned to olympus original equipment manufacturer (oem) for evaluation. The oem evaluation confirmed the reported probe damage. The strength of the cavitation bubble on this probe type could likely drive the head of the probe backwards as the insulation breaks down. The oem confirmed that the reported phenomenon could be related to a known device issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2016-00686 |
| MDR Report Key | 5873813 |
| Date Received | 2016-08-12 |
| Date of Report | 2016-10-31 |
| Date of Event | 2016-07-26 |
| Date Mfgr Received | 2016-10-06 |
| Date Added to Maude | 2016-08-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DONNY SHAPIRO |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9FR. EHL PROBE FOR AEH-4 |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2016-08-12 |
| Model Number | E4-9F |
| Catalog Number | E4-9F |
| Lot Number | NG912050 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTHGATE TECHNOLOGIES |
| Manufacturer Address | 1591 SCOTTSDALE COURT ELGIN 60123 US 60123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-12 |